PhRMA Applauds Innovation, Access Policies in US-Japan Report

PhRMA Applauds Innovation, Access Policies in US-Japan Report

Washington, D.C. (July 8, 2009) – PhRMA President of International Christopher Singer issued the following statement today on this year’s annual report to President Obama and Prime Minister Aso under the U.S.-Japan Regulatory Reform and Competition Policy Initiative:

“PhRMA members appreciate the special focus the report places on regulatory and market access issues related to pharmaceuticals. In particular, we welcome steps taken by the Japanese Government to ensure it establishes drug prices in a manner that recognizes the value of innovation and the need for timely access to pharmaceuticals by the people of Japan.

“We also applaud the U.S. Government for its strong statement in opposition to a market-expansion repricing rule. The market-expansion repricing mechanism has been inconsistent with Japan’s assurances to consider the value of innovation and ensure timely access to life-saving medicines for Japanese patients. The U.S. Government should also be commended for its strong statement urging the Japanese Government to avoid implementing its annual price revisions.

“The report specifically notes that Japan will provide meaningful opportunities for America’s pharmaceutical research and biotechnology companies to consult with the government on the government’s pricing rules, including frequency of reimbursement price revisions, and regulatory procedures and will allow for more transparency in the government price-setting process.

“The innovative pharmaceutical industry recognizes the challenges faced by the Japanese Government in creating a high-quality, sustainable healthcare system that encourages the development of new medicines and meets the needs of patients. We value our role as a recognized, legitimate partner in Japan’s healthcare system, and want to make a constructive contribution to the healthcare reform dialogue.

“PhRMA supports fundamental reform of the system to put patients first, by treating health care as a critical, life-saving investment and ensuring their access to healthcare information, and new, innovative medical treatment. Such reforms not only improve the quality of life, but can lead to lower healthcare costs through more appropriate allocation of resources such as fewer people requiring surgery, costly hospitalization and long recovery periods.

"PhRMA also welcomes steps taken by the Japanese Government to shorten approval times for new drugs as well as the productive dialogue that the Japanese regulatory authorities is having with our industry to identify concrete process improvements. PhRMA welcomes the increased willingness that Japanese regulators are demonstrating toward including Japan into global new drug development plans. We are hopeful that these, and additional efforts, will contribute to the shortening of new drug approval times in Japan.

“PhRMA appreciates the ongoing efforts on the part of the U.S. Government and the Government of Japan and hope that any future reforms will continue to move in this direction.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.